This project's primary goal was to study the primary labels (PL) and primary cartons labels and patient
information leaflets (PIL) for their suitability, harmonisation, and compliance with legal and regulatory
standards. In the study, the PL, primary carton label, and PIL of innovator and generic products were
evaluated side by side. For this study, three distinct marketed brands of diclofenac injection IP—the
innovator product, classified as brand A, and two generic versions, coded as brands B and C—were taken
into consideration. The purpose of the survey study, which was question-based, was to determine if nurses
were aware of labelling problems. The study found that the PL, primary carton label, and PIL of the
innovator product were devoid of negative, significant, and minor findings. However, it was discovered
that all three types of observations were present in generic brands' PL, primary carton labels, and PIL.
Nursing personnel were unaware of the mistakes detected in the labels and believed the information to be
accurate because of their normal workload and the hectic hospital ward activities. It’s necessary to assure
uniform and standard text matter content across PL, primary carton labels and PIL, thus, avoiding
misleading information to healthcare professionals and patients.
Keywords: Patient information leaflet, Primary label, Primary carton, Text matter,
Harmonization, Diclofenac injection IP
Publication date: 01/10/2024
https://ijbpas.com/pdf/2024/October/MS_IJBPAS_2024_8352.pdf
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https://doi.org/10.31032/IJBPAS/2024/13.10.8352
